A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)
NCT02179918
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available.
- Measurable disease per RECIST v1.1.
- Adequate bone marrow, renal and liver functioning
- CNS primary malignancies, active seizure disorder or spinal cord compression, or
carcinomatous meningitis.
- History of any of the following toxicities associated with a prior immunotherapy:
- Grade 3 immune mediated adverse event that was considered related to previous
immunotherapy and required immune suppressive therapy;
- Grade 2 hepatic function related adverse event that persisted more than 1 week,
was considered related to immunotherapy, or required treatment discontinuation or
immunosuppressive therapy
- Any of the following within the 12 months prior to registration: myocardial
infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic
congestive heart failure, cerebrovascular accident or transient ischemic attack and 6
months for deep vein thrombosis or pulmonary embolism.
- History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4
interstitial fibrosis or interstitial lung disease, including a history of
pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung
disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a
history of prior radiation pneumonitis. Patients with clinically significant lung
disease requiring oxygen therapy (eg, COPD).
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New Lambton Heights, New South Wales
- New Lambton Heights, New South Wales
- Downey, California
- Encinitas, California
- Glendale, California
- Long Beach, California
- Los Angeles, California
- Los Angeles, California
- Santa Ana, California
- Whittier, California
- Whittier, California
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- Lake Mary, Florida
- Kansas City, Missouri
- Bronx, New York
- Cincinnati, Ohio
- Cleveland, Ohio
- West Chester, Ohio
- Pittsburgh, Pennsylvania
- Pittsburgh, Pennsylvania
- Pittsburgh, Pennsylvania
- Dallas, Texas
- San Antonio, Texas
- Liverpool, New South Wales
- Liverpool, New South Wales
- Washington, District of Columbia
- Los Angeles, California
- Los Angeles, California
- Santa Monica, California
- Aurora, Colorado
- Aurora, Colorado
- Port Saint Lucie, Florida
- Fort Wayne, Indiana
- Fort Wayne, Indiana
- Fort Wayne, Indiana
- Fort Wayne, Indiana
- Lafayette, Indiana
- Cedar Rapids, Iowa
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Detroit, Michigan
- Rochester, Minnesota
- Saint Paul, Minnesota
- Saint Paul, Minnesota
- Saint Paul, Minnesota
- Saint Paul, Minnesota
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- San Antonio, Texas
- Salt Lake City, Utah
- Salt Lake City, Utah
- Charlottesville, Virginia
- Charlottesville, Virginia
- Budapest,
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036) | ||||
Official Title ICMJE | A PHASE 1B STUDY OF THE 4-1BB AGONIST PF-05082566 IN COMBINATION WITH THE PD-1 INHIBITOR MK-3475 IN PATIENTS WITH ADVANCED SOLID TUMORS | ||||
Brief Summary | This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in patients with solid tumors. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Advanced Solid Tumors | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE | Experimental: PF-05082566 +MK-3475
PF-05082566 +MK-3475 Interventions:
| ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 23 | ||||
Original Estimated Enrollment ICMJE | 45 | ||||
Actual Study Completion Date ICMJE | February 2017 | ||||
Actual Primary Completion Date | February 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02179918 | ||||
Other Study ID Numbers ICMJE | B1641003 KEYNOTE-0036 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Merck Sharp & Dohme Corp. | ||||
Investigators ICMJE |
| ||||
PRS Account | Pfizer | ||||
Verification Date | January 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |